Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

  • Kidney Disorder
  • Renal Anemia
  • Chronic Kidney Disease
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • France
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Spain
  • United States
Trial Identifier:

NCT03552393 2016-004779-39 NH19708

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial Summary

      Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT03552393, NH19708, 2016-004779-39 Trial Identifier
      Mircera Treatments
      Anemia, Renal Insufficiency, Chronic Condition
      Official Title

      An Open-Label, Single-Arm, Multicenter Study to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

      Eligibility Criteria

      All Gender
      ≥ 3 Months & ≤ 17 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Pediatric participants 3 months to 17 years of age with clinically stable chronic renal anemia
      • CKD with estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2 (determined by the Bedside Schwartz formula) or dialysis treatment for at least 8 weeks before the first dose of Mircera
      • For participants on peritoneal dialysis (PD): a weekly Kt/V≥ 1.8
      • For participants on hemodialysis (HD): adequate HD, urea reduction ratio (URR) > 65% or Kt/V > 1.2 for participants on HD three times per week.

      Participants with fewer than or more than three HD sessions per week should have a weekly Kt/V≥ 3.6.

      • Baseline Hb concentration 10.0-12.0 g/dL determined from the mean of two Hb values measured at Visit 1 (Week -3) and Visit 2 (Week -1)
      • Stable SC maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa with the same dosing interval for at least 6 weeks before the first dose of Mircera
      • Stable dose of epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change > 25% (increase or decrease) for at least 4 weeks before the first dose of Mircera
      • Adequate iron status defined as ferritin≥100 ng/mL or transferrin saturation (TSAT)≥ 20% (or percentage of hypochromic red cells < 10%); mean of two values measured during screening.
      Exclusion Criteria
      • Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
      • RBC transfusions within 8 weeks before screening or during the screening period
      • Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) Hemolytic anemia, Active malignant disease
      • PD subjects with an episode of peritonitis within the past 30 days prior to screening and/or during the screening period
      • Uncontrolled or symptomatic inflammatory disease (e.g., systemic lupus erythematosus)
      • Uncontrolled hypertension as assessed by the investigator
      • Epileptic seizures within 3 months prior to screening and during the screening period
      • Administration of any investigational drug within 4 weeks prior to screening or planned during the study
      • Severe hyperparathyroidism (intact parathyroid hormone [PTH]≥ 1000 pg/mL or whole PTH≥ 500 pg/mL) or biopsy-proven bone marrow fibrosis
      • Kidney transplant with use of immunosuppressive therapies known to exacerbate anemia
      • Known hypersensitivity to recombinant human erythropoietin (EPO), polyethylene glycol, or any constituent of the study drug formulation
      • Anti-EPO antibody (AEAB)-mediated pure red cell aplasia (PRCA) or history of AEAB mediated PRCA or positive AEAB test result in the absence of PRCA
      • High likelihood of early withdrawal or interruption of the study (e.g., planned living donor kidney transplant within 5 months of study start)
      • Planned elective surgery during the entire study period

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